2025 年第 7 期 第 20 卷

含米诺环素及左氧氟沙星的铋剂四联方案在幽门螺杆菌感染患者中的应用

The application of bismuth quadruple therapy containing minocycline and levofloxacin in patients with Helicobacter pylori infection

作者：张月霞张灵云蓝宇司小北

英文作者：Zhang Yuexia Zhang Lingyun Lan Yu Si Xiaobei

单位：首都医科大学附属北京积水潭医院消化内科，北京100096

英文单位：Department of Gastroenterology Beijing Jishuitan Hospital Capital Medical University Beijing 100096， China

关键词：幽门螺杆菌；米诺环素；左氧氟沙星；铋剂四联方案；根除率

英文关键词：Helicobacterpylori;Minocycline;Levofloxacin;Bismuthquadrupleregimen;Eradicationrate

• 摘要：

• 目的 探讨含米诺环素及左氧氟沙星的铋剂四联方案在幽门螺杆菌（Hp）感染初治患者中的根除率及安全性等。方法 选取2022年1月至2023年10月在首都医科大学附属北京积水潭医院就诊的Hp感染初治患者(280例)，按照随机数字表法分为米诺环素及左氧氟沙星组（观察组)和阿莫西林及克拉霉素组（对照组)，各140例，均联合雷贝拉唑及枸橼酸铋钾组成四联方案，疗程14 d。用药结束3~5 d随访患者用药安全性与依从性；4~12周复查 13C尿素呼气试验明确Hp根除率。结果 意向性治疗（ITT）分析（研究中因拒绝服药剔除1例后观察组139例、对照组140例）、遵循方案分析（PP分析）（去掉后续被剔除患者后观察组和对照组均为134例）显示观察组根除率均高于对照组［ITT分析：92.1%（128/139）比80.7%（113/140）， χ2=7.667，P=0.006；PP分析：95.5%（128/134）比84.3%（113/134）， χ2=9.267，P=0.002］。年龄、性别、体重指数、内镜下表现、吸烟等对根除率均无显著影响（均P＞0.05）。观察组味觉异常比例低于对照组（P＜0.05），2组其他不良反应比较差异均无统计学意义（均P＞0.05）。结论 含米诺环素及左氧氟沙星的铋剂四联方案在Hp初治患者中的根除率理想，安全性及依从性较好。

• Objective  To investigate the eradication rate and safety of bismuth-based quadruple therapy containing minocycline and levofloxacin in newly diagnosed patients with Helicobacter pylori (Hp) infection. Methods A total of 280 patients with Hp infection who were initially treated in Beijing Jishuitan Hospital, Capital Medical University from January 2022 to October 2023 were enrolled.According to the random number table method, they were divided into minocycline and levofloxacin group (observation group) and amoxicillin and clarithromycin group (control group), with 140 cases in each group. Both groups were combined with rabeprazole and bismuth potassium citrate to form a quadruple regimen for 14 days. The medication safety and compliance of patients were followed up for 3 to 5 days after the end of medication. Hp eradication rate was determined by 13C urea breath test after 4 to 12 weeks. Results Intention-to-treat (ITT) analysis (One case was excluded in the study due to refusal to take medication, afterwards 139 cases in the observation group and 140 cases in the control group) and protocol-following (PP) analysis (after removing the subsequently excluded patients, both the observation group and the control group had 134 cases) showed that the eradication rates of the observation group were higher than those of the control group ［ITT analysis: 92.1% (128/139) vs 80.7% (113/140), χ2=7.667, P=0.006; PP analysis: 95.5% (128/134) vs 84.3% (113/134), χ2=9.267, P=0.002］. Age, sex, body mass index, endoscopic findings and smoking had no significant effect on the eradication rate (all P>0.05). The proportion of abnormal taste in the observation group was lower than that in the control group (P<0.05). There was no significant difference in other adverse reactions between the two groups (all P>0.05). Conclusion The bismuth-based quadruple therapy containing minocycline and levofloxacin has an ideal eradication rate, safety and compliance in Hp naive patients.